Assay

Anti-SARS-COV-2 Antibodies

Key Words

ACOV, ACOV2, COVID-19 serology, nucleocapsid

Specimen Collection

Serum (brown)

Turnaround Time

24hrs

Test Indications

The SARS-CoV-2 (COVID-19) virus consists of 4 structural proteins spike (S), envelope (E), membrane (M), and nucleocapsid (N). This test uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS CoV 2. As such it cannot be used for the monitoring of vaccine response or determining suitability for COVID-19 monoclonal antibody therapy. This assay has been validated in patients with clinically confirmed COVID-19 (SARS CoV-2) PCR positivity from upper respiratory tract swabs.

The assay in this cohort has a sensitivity of 90% and specificity of 100% two weeks after confirmed COVID-19 (SARS CoV-2) PCR positivity (local verification data). A positive result does not confirm protection against SARS CoV-2 infection, or the ability of the antibody to neutralise the SARS CoV-2 virus.

Management decisions must continue to be based on clinical presentation and SARS CoV-2 PCR result as per established guidelines.

For details of the Anti-SARS-CoV-2 S (spike) antibody assay, please see (http://www.pch-pathlab.com/cms/?q=node/747)

Limitations/Interferences

No known common methodological interferences.

Reference Range

Reported as 'Positive' or 'Negative'

Negative - No serological evidence of SARS-CoV-2 infection. 

Positive - Consistent with exposure to SARS-CoV-2 at some time.

This test detects both IgG and IgM, but a history of symptoms or confirmed COVID-19 at least

six weeks ago makes active infection less likely.

Analytical Error

6.2%

Reference Change Value

Not applicable

Minimum retesting interval

Not applicable